Quality Assurance Manager

Job Description Summary

The Manager – Quality Assurance is responsible for providing guidance, support, and expertise in maintaining regulatory compliance according to established standard operating procedures and applicable regulatory requirements. The Manager – Quality Assurance should develop a sense of responsibility toward their duties.

• Bachelor’s degree or at least 5 years of relevant work experience.
• At least 5+ years of applicable work experience.
• At least 3+ years of experience in quality, auditing and/or project management.
• Demonstrated experience and working knowledge of applicable regulations as they relate to EPL Archives services.
• Strong communication skills (both written and oral).
• Ability to work independently when necessary and participate in a team environment.
• Ability to balance and coordinate workload for multiple projects.
• Ability to maintain strict confidentiality regarding all matters concerning the company, its customers, and employees.
• Ability to use Microsoft Office (Word, Excel and PowerPoint).
• Superior role model leadership behaviors – ability to lead and motivate others while displaying integrity, intensity, innovation, and involvement.

• Completion of the orientation program with an understanding of our work, how it must be completed in compliance with applicable U.S. and OECD regulations and our Standard Operating Procedures.
• Understanding of Chemical Safety and the proper use of safety equipment.
• Communication of the company’s quality program to internal and external stakeholders.
• Participation in the development of processes and procedures that meet quality standards.
• Participation and/or oversight of regulatory training and development.
• Participation and/or oversight of company audit programs.

• Develops and manages the quality strategy for the site(s) in alignment with the quality function and overall company goals.
• Creates a quality-focused culture through collaboration, training, metrics, and risk-based assessments.
• Works with various functions, including operations, client services, facilities, and IT to develop, implement, and continuously improve the Quality Management System.
• Manages the development of quality assurance staff, including coaching and development recommendations through performance reviews.
• Manages the daily operation of the quality assurance unit, including maintenance of an effective system for completion of day-to-day work assignments, indexing of quality assurance records, and oversight of the regulatory training program.
• Evaluates overall compliance of the EPL Archives facility with applicable standard operating procedures (SOPs) and regulatory requirements through internal facility and process-focused inspections.
• Ensures proper distribution of findings to Archives Management personnel and staff for resolution, including initiation of SOP changes based on inspection findings.
• Develops and coordinates changes to SOPs, controls, and procedures sufficient to successfully satisfy any audit or other regulatory review performed by FDA, EPA, and other agencies.
• Provides oversight for Corrective Action Investigations.
• Leads and coordinates regulatory/client/facility audit response and SOP updates between EU/US sites, ensuring continuity of procedures between sites.
• Maintains all inspection activity records; identifies, documents and reports deviations from applicable regulations and SOPs to Archives Management, ensuring appropriate corrective actions have been completed.
• Collects and distributes periodic reports to Archives Management summarizing deviation trending, client complaints, and corrective action investigation status.
• Develops and manages a Vendor Assessment Program, including scheduling and conducting critical vendor/supplier assessments for suitability of use, and distributing findings to Archives Management personnel and vendors for resolution.
• Serves as QA lead for client inspections, performing associated duties such as agendas, summary reports, and follow-up to ensure resolution of findings.
• Acts as the primary point of contact with responsibility to manage regulatory inspections and…